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Multiple Dose Clinical Trial of TorreyPines Therapeutics' Tezampanel Demonstrates Compound is Safe and Well-Tolerated
Date:2/5/2008

- Findings Support Continued Development for Chronic Pain and Non-Pain

Indications -

LA JOLLA, Calif., Feb. 5 /PRNewswire/ -- TorreyPines Therapeutics, Inc. (Nasdaq: TPTX) today announced that data from its multiple dose clinical trial of tezampanel, an antagonist of the AMPA and kainate subgroup of glutamate receptors, show that the product candidate is safe and well-tolerated in normal male and female subjects.

These Phase I results support the company's continued development of tezampanel as a novel therapeutic for chronic pain and expand its potential therapeutic applications across a variety of persistent conditions in which activation of glutamate receptors initiates or sustains pathophysiological processes. These conditions include cancer pain and neuropathic pain, as well as non-pain conditions such as epilepsy, muscle spasticity and rigidity, and Parkinson's disease. A recently completed Phase IIb clinical trial of tezampanel in 306 patients with migraine met its primary endpoint for pain relief at two hours using a single 40 mg subcutaneous dose. In five previously conducted placebo-controlled, Phase II trials, an intravenous formulation of tezampanel demonstrated analgesic effect across all five studies using a variety of chronic pain models.

The Phase I double-blind, placebo-controlled trial enrolled 30 healthy male and female subjects in sequential, dose-escalating cohorts. Subjects received once-daily subcutaneous injections of placebo or 40 mg, 70 mg or 100 mg of tezampanel for four consecutive days, approximating exposure under steady-state pharmacokinetic conditions. Overall, tezampanel was well-tolerated. There were no dose-limiting adverse events or discontinuations f
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SOURCE TorreyPines Therapeutics, Inc.
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